Actively Recruiting
Chimeric Natural Killer Receptor-Universal T Cells for Refractory GVHD
Led by Fujian Medical University · Updated on 2024-08-23
17
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single arm, open-label, multi-center, pilot studies (Investigator Initiated Trial, IIT) to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of universal T-cells engineered with chimeric natural killer receptor (CNK-UT) to treat the patients with steroid-refractory/resistant or steroid-dependent GVHD.
CONDITIONS
Official Title
Chimeric Natural Killer Receptor-Universal T Cells for Refractory GVHD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 1 to 70 years, male or female
- Diagnosed with grade II to IV steroid-refractory, resistant, or steroid-dependent GVHD after allogeneic hematopoietic stem cell transplantation
- Failed treatment with ruxolitinib or at least one other second-line medication, or intolerant to these medications
- ECOG physical status score between 0 and 3
- Estimated life expectancy greater than 12 weeks
- Female participants of childbearing age must have a negative pregnancy test before enrollment and agree to use effective contraception during the trial
- Participants (male or female) agree to use effective contraception during the study and for at least 6 months after the last dose
- Voluntarily agree to participate, understand the study, sign informed consent, and follow all procedures
You will not qualify if you...
- Have malignant tumors diagnosed within 5 years before enrollment, except certain skin cancers and carcinoma in situ that have been radically treated
- History of organ transplantation
- Previously undergone more than one allogeneic hematopoietic stem cell transplantation
- Uncontrolled hypertension or history of hypertensive crisis or encephalopathy
- Symptomatic congestive heart failure (NYHA class III-IV), symptomatic or poorly controlled arrhythmias, congenital long QT syndrome, or QTc > 500 ms at screening
- Unstable systemic diseases requiring pharmacological treatment, excluding transplantation-related complications
- Active pulmonary tuberculosis or treatment for TB within 1 year
- HIV infection or known syphilis infection
- Severe active or poorly controlled infections
- Participation in other clinical trials within 12 weeks prior to this study
- Prior use of any gene therapy products
- Allergy to components of CNK-UT injection
- Known mental or substance abuse disorders interfering with compliance
- Pregnant or breastfeeding women, or planning birth within 1 year after treatment
- Uncontrolled or uncorrectable metabolic or non-malignant organ/systemic diseases increasing medical risk
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Actively Recruiting
Research Team
T
Ting YANG, Prof.
CONTACT
J
Jianda HU, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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